In the treatment of human patients or in experimentel medicine, especially for the treatment of incontinence, it is desirable to provide means for selectively obstructing or obdurating the natural or synthetic tubular body organs through which certain body materials can pass. In the case of incontinence, it is desirable to block the uretha or other urine-passing duct while, in other cases, it is desirable to prevent the passage of solid and semi-solid wastes through portions of the intestine, the colon, or other ducts connected thereto.
Various devices for this purpose have been provided to enable, for example, a patient to control the passage of body materials through such natural and artificial tubular body organs. Such devices are designed to simplify the normal body functions. Such devices have utility where the normal constricting muscle system has been rendered inoperative by disease, operation or accident.
Such conventional devices can be subdivided into two groups. A first group comprises devices which are disposed externally of the body and provide a closure for the natural or synthetic body opening and can include a collecting vessel for the materials which are discharged. Typical of such devices are those disclosed in Austrian Pat. No. 172,942 and U.S. Pat. No. 2,423,060.
Such devices are not always satisfactory and certainly are less than aesthetic and desirable so that it has been considered important to provide the closure device within the body. The second group of conventional devices are designed to provide such internal closures. In general, these devices are intended to constrict synthetic or natural tubular body openings.
In some cases, this is accomplished by expanding (inflating) an elastic body inserted into the tubular body organ (see Austrian Pat. No. 169,094 and U.S. Pat. No. 2,324,520). A device of the last-mentioned type has been described in the publication Medical Tribune, Internationale Wochenzeitung-Ausgabe fur Osterreich, No. 13, 1976, published by Medical Tribune GmbH, Wiesbaden, Germany.
The closure device here comprises an inflatable sleeve which is disposed around the portion of the intestine to be blocked and is connected by two conduits with a liquid supply vessel disposed also within the body but sufficiently close to a depressable portion thereof so that a balloon pump as well as a valve system can be actuated to effect transfer of fluid from the supply vessel to the sleeve and, via the valve system, from the sleeve into the supply vessel. Such devices have been found to be satisfactory in animal tests.
An important difficulty with this earlier system, however, resides in the complexity thereof and the relatively large number of parts, units or devices which must be implanted in the body, i.e. a sleeve, a supply vessel, two connecting conduits, two balloon pumps and valves. This not only makes the unit difficult to operate, but also creates problems with respect to reliability since the more complex the system, the less reliable it tends to be. Problems have also been encountered with such systems with respect to the failure of the seals at the connecting locations, wear and failure of the valves and the like. Furthermore, because of the large number of parts foreign to the body, there is an increased danger of infecton, necrosis and undesirable cell development around the inserted parts.
Another device which has been introduced into the body entirely is described in Volume 325, pp 1170-1174, of Langenbeck's Archiv fur klinische Chirurgie, Springer-Verlag, Berlin, Germany, 1969.
This device also comprises a pressurizable sleeve which is disposed around a tubular body organ. The sleeve is connected by a conduit to a micropump disposed in a housing and connected by a further conduit to a supply vessel which also can be disposed in the body. The micropump in the housing is electrically driven and the energy for operating this pump is transmitted thereto by a unit disposed outside the body and is picked up by an oscillator circuit (receiver) disposed in the housing of the micropump and supplied to the latter by an electric circuit. The direction of operation of the pump is also controlled by the transmitter.
This system also suffers from a disadvantage that a relatively large number of foreign bodies must be introduced into the human or animal organism, although the system has the advantage that valves are unnecessary. A further disadvantage of the latter system is that an external unit, namely the energy transmitter, is required for satisfactory functioning of the device. Should the patient lose the transmitter, or should the transmitter fail when the tubular body organ is blocked, its opening is not possible and the life of the patient as well as the patient's comfort are in danger.